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University of Toronto | Leslie Dan Faculty of Pharmacy
WORLD HEALTH ORGANIZATION COLLABORATING CENTRE
GOVERNANCE, ACCOUNTABILITY & TRANSPARENCY
IN THE PHARMACEUTICAL SECTOR
Activities Report
October 2015 to January 2018
Director Dr. Jillian C. Kohler
COPYRIGHT © 2018
2
TABLE OF CONTENTS
ABOUT US 3
WHO WE ARE 4
DIRECTORS 4
RESEARCH FELLOWS AT UNIVERSITY OF TORONTO 4
GLOBAL RESEARCH FELLOWS 5
WORKSHOPS, SYMPOSIUMS, COURSES & INTELLECTUAL SALONS 6
PUBLICATIONS & KNOWLEDGE DISSEMINATION 9
SUMMARY 22
FUTURE DIRECTIONS 22
3
ABOUT US
The World Health Organization (WHO) Collaborating Centre for Governance, Accountability and
Transparency in the Pharmaceutical Sector was convened in 2015 and is currently led by Dr. Jillian C.
Kohler, at the Leslie Dan Faculty of Pharmacy (University of Toronto).
Our mission is to conduct research, analysis and training on critical issues related to
good governance and transparency in medicines.
The Collaborating Centre has three objectives:
To use existing research facilities at the University of Toronto for pharmaceutical policy
research, analysis, and training on critical issues related to good governance and
transparency in medicines, in collaboration with the WHO.
To ensure global dissemination of knowledge on the issues related to good governance and
transparency by establishing a global network of researchers, policy makers, and advocates
in coordination with the WHO.
To support collaboration and help intensify the work of the WHO in areas related to good
governance and transparency in medicines.
TERMS OF REFERENCE
The WHO Collaborating Centre for Governance, Accountability and Transparency in the Pharmaceutical
Sector (WHO CCGAT) conducts the following activities:
Policy Workshops, Symposiums and Seminars
Undergraduate and Graduate Courses
Information Dissemination and Media
These activities and their outputs are further described throughout the report.
4
Who We Are
This WHO Collaborating Centre (WHO CC) involves the following multidisciplinary team of directors,
faculty members, research fellows and global collaborators:
Directors
Research Fellows at University of Toronto
DR. JILLIAN C. KOHLER
Director
DEIDRE DIMANCESCO
Technical Director
Leslie Dan Faculty of Pharmacy
University of Toronto
Medicines Policy, Access & Rational Use
World Health Organization
DR. ZUBIN AUSTIN DR. SUZANNE CADARETTE DR. JOHN FARRELL
Professor
Leslie Dan Faculty of
Pharmacy
Associate Professor
Leslie Dan Faculty of
Pharmacy
Executive Director
Centre for Practice
Excellence
DR. SARA GUILCHER
DR. PAUL GROOTENDORST DR. ALISON THOMPSON
Associate Professor
Leslie Dan Faculty of
Pharmacy
Associate Professor
Leslie Dan Faculty of
Pharmacy
Associate Professor
Leslie Dan Faculty of
Pharmacy
DR. ERICA DIRUGGIERO DR. LISA FORMAN DR. ANITA MCGAHAN
Associate Professor
Dalla Lana School of Public
Health
Associate Professor
Dalla Lana School of Public
Health
Professor
Munk School of Global
Affairs
DR. JOSEPH WONG DR. JOEL LEXCHIN DR. TRUDO LEMMENS
Professor
Munk School of Global
Affairs
Associate Professor
Faculty of
Medicine
Associate Professor
Faculty of
Law
DR. NAV PERSAUD DR. MARIANA PRADO
Associate Scientist
Li Ka Sing Knowledge
Institute
Associate Professor
Faculty of
Law
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Global Research Fellows
Contact Us:
Leslie Dan Faculty of Pharmacy
University of Toronto
144 College Street
Toronto, Ontario, M5S3M2
Tel: 416-946-8708 | Fax: 416-978-1833
Email: [email protected]
Website: http://www.pharmacy.utoronto.ca/whocc
DR. TIM K. MACKEY DR. MARC-ANDRÉ GAGNON DR. VARUN GAURI
Assistant Professor
Anesthesiology and Global
Public Health
(University of California)
Associate Professor
School of Public
Policy & Administration
(Carleton University)
Head & Senior Economist
Global Insights Initiative
(Development Research
Group)
DR. MATTHEW HERDER
Associate Professor
Faculty of Medicine
(Dalhousie University)
6
Workshops, Symposiums, Courses & Intellectual Salons
2017-2018
January 18, 2018
Health Law, Ethics & Policy Seminar Series: The Benefit and Risks of Expedited Development and
Regulatory Approval of New Drugs
Along with the Faculty of Law, University of Toronto, the WHO CC sponsored a lunchtime seminar on
the topic of expedited drug approval processes. The key speaker was Dr. Aaron Kesselheim and the
commentator was Dr. Megan Bettle from Health Canada. (Link: https://www.law.utoronto.ca/scholarship-publications/workshops-and-seminars/health-law-ethics-and-
policy-seminar-series)
Outcomes: Professionals, community members and students were able to engage in a stimulating discussion on
relevant and topical issues related to drug approval processes in North America. Attendees learned
about streamlined drug development processes in the US, their implications and how they compare to
Canada.
January 17, 2018
Idea Salon with Dr. Aaron Kesselheim: Expedited Development & Regulatory Approval of New
Drugs
A dinner with experts from the Ontario and Federal Governments, academia and the non-governmental
organization (NGO) community was hosted at the University of Toronto’s Faculty Club, in advance of
Dr. Kesselheim’s seminar presentation to discuss related issues in a smaller, off-the record setting.
Outcomes: Experts were able to meaningfully share ideas and engage in a small-group discussion on this topic.
Attendees also raised critical thoughts on related and relevant issues. This salon successfully connected
leading-thinkers from NGOs, academic institutions, as well as federal and Ontario governments.
September 29, 2017
Governance of Pharmaceuticals Policy Workshop
Internationally renowned experts gathered for this workshop to discuss the impacts of corruption and
lack of good governance on the pharmaceutical sector. This one-day course was offered to researchers,
policy makers, the private sector, and undergraduate and graduate students at the University of Toronto. (Link: http://www.pharmacy.utoronto.ca/sites/default/files/upload//who_cc/sept17-
workshop/Sept%202017%20Workshop%20Agenda.pdf)
Outcomes: Participants learned about how corruption and a lack of good governance can have an impact on the
pharmaceutical sector. Participants also learned about strategies and tactics for countering
vulnerabilities in this sector. Learning materials are available online on our WHO CC website.
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September 28, 2017
Tackling corruption in procurement: how open contracting improved healthcare in Nigeria, Ukraine
and Honduras
This workshop was presented by Lucas Amin (Transparency International, UK). (Link: http://www.pharmacy.utoronto.ca/sites/default/files/upload//who_cc/Sept28%2C2017-Amin.Kohler.pdf)
Outcomes: A presentation on the challenges with drug procurement was delivered to an audience of graduate
students in the Department of Pharmaceutical Sciences.
May 24, 2017
Processes for Developing and Updating an Essential Medicines List in Canada?
This policy meeting was led by a WHO CCCGAT Research Fellow, Dr. Nav Persaud.
Outcomes: This workshop led to important discussions with several policymakers, including representatives from
the Ontario Ministry of Health and Long-Term Care, Alberta Health, the Newfoundland and Labrador
Department of Health and Community Services, Manitoba Health, British Columbia Ministry of
Health, Patented Medicine Prices Review Board, the Canadian Agency for Drugs and Technology in
Health (CADTH), Canadian Institute for Health Information, and Health Canada.
May 23, 2017
Should Canada Develop a List of Essential Medicines?
This seminar was presented by the WHO Secretary of the Expert Committee on the Selection and Use
of Essential Medicines, Dr. Nicola Magrini and Lars Gustaffson, a Professor in the Department of
Laboratory Medicine at Karolinska University. (Link: https://munkschool.utoronto.ca/event/23013/)
Outcomes: A presentation on the benefits and challenges of creating an essential medicines list was delivered. The
opinions and reactions of Canadian decision-makers were discussed, followed by an open public forum
discussion to involve all participants.
February 2, 2017
Access to Medicine – Benchmarking Pharmaceutical Companies in Weak Regulatory Environments
This seminar was presented by Luca Genovese, a researcher with the Access to Medicine Foundation.
This was co-hosted by the Leslie Dan Faculty of Pharmacy, Universite Sainte Anne, and Carleton
University Faculty of Public Affairs and the WHO CCGAT. (Link:
http://www.pharmacy.utoronto.ca/sites/default/files/upload//who_cc/Feb%202%20-%20Genovese.Kohler.pdf)
Outcomes: A report from this symposium was published in the Canadian Medical Association Journal.
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2015-2016
November 28, 2016
Symposium
Governance and Corruption in the Pharmaceutical Sector: Causes and Consequences
The keynote speaker for this symposium was Dr. Sidney Wolfe (Co-founder; Public Citizen’s Health
Research Group). The event was co-hosted by the Leslie Dan Faculty of Pharmacy, Universite Sainte
Anne, and Carleton University Faculty of Public Affairs and the WHO CCGAT. (Link:http://www.pharmacy.utoronto.ca/sites/default/files/upload//who_cc/Symposium%20on%20Combating%2
0Corruption%20in%20Health%20Care%20and%20PharmaceuticalsC.pdf)
Outcomes:
This was the first policy workshop of the 2016-2017 work program and led to a multidisciplinary
discussion on legal, financial and ideological varieties of corruption.
April 29, 2016
Taking the Pulse of Governance, Accountability and Transparency in the Pharmaceutical Sector:
Diagnosing the Issues
This policy workshop included a series of presentations led by multiple experts, researchers and
students. (Link:http://www.pharmacy.utoronto.ca/sites/default/files/upload//who_cc/Save%20the%20date%20WHO%20C
C%20launch.pdf)
Outcomes:
A series of presentations were provided from research fellows and experts in the field. Notes and an
overview from this workshop is available on our WHO CC website.
April 28, 2016
Corruption and the Pharmaceutical & Healthcare Sector: Global Policy & Structural Issues
This meeting was led by James Sale, a Project Officer from Transparency International (UK). (Link:http://www.pharmacy.utoronto.ca/sites/default/files/upload//who_cc/SALE.James%20Apr%2028%20-%20
Kohler.pdf)
Outcomes:
This seminar provided graduate students and attendees with knowledge on the topic of corruption.
9
Publications & Knowledge Dissemination
Presentations from Conferences (chronological order):
April 2016. Panel at Consortium for Universities for Global Health – San Francisco:
o Are Current Anti-Corruption Tools in the Health Sector Good Enough for Health Security? Speakers – Josh Michaud, Kaiser Foundation, Jillian C Kohler (WHO CC and LDFP),
Maureen Lewis (Georgetown University), Taryn Vian (Boston University), Tim Mackey
(University of San Diego).
o Corruption and Global Health Security: Tools for Health Security. Taryn Vian, SM, PhD,
Associate Professor of Global Health Boston University School of Public Health.
o Corruption in Global Health: Scope, Diversity, Case Studies, Tools, and Legal Frameworks
Tim Mackey, MAS, PhD, Assistant Professor, UC San Diego – School of Medicine.
o Transparency and Accountability in Pharmaceutical Pricing and Procurement: Are Current
Anti-Corruption Tools in the Health Sector Good Enough for Health Security? Jillian Clare
Kohler, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
Director, WHO Collaborating Centre for Governance, Transparency and Accountability in
the Pharmaceutical Sector.
o An Evaluation on of Accountability and Transparency in Brazil’s Pharmaceutical System
(Abstract) Martinez MG (Leslie Dan Faculty of Pharmacy, University of Toronto), Kohler
JC (Leslie Dan Faculty of Pharmacy, University of Toronto) (Winner of the 2016 Lancet-
Consortium of Universities for Global Health Annual Meeting - Best Student Poster Track:
Governance).
October 2016. Workshop co-presenter, Beyond medicalization: an international view of MD roles
in long term care, Ontario Long Term Care Clinicians, Toronto. Presenter: Lexchin, J.
October 2016. Panelist, Plenary panel: big pharma and health care. Annual conference, Council of
Canadians, St. John's. Presenter: Lexchin, J.
October 18, 2016. Twitter Analysis and Drug Abuse: Discussion About Data Collection,
Methods, Analysis, and Recent Research. Mackey TK. UCSD Human Nature Group - Public
Health, San Diego, CA Presenter: Mackey, TK.
October 31, 2016. Joint Comprehensive Plan of Actions: An Opportunity for Applied Health
Diplomacy? Session Title: "Health Diplomacy: A Tool for Mobilizing the Right to Health"
Mackey TK. 2016 American Public Health Association Annual Meeting, Denver, CO. Presenter:
Mackey, TK.
November 2016. Drug prices in the United States. Webinar for American Medical Students
Association. Presenter: Lexchin, J.
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November 28, 2016. "Corruption of the Canadian drug regulatory system". Combating corruption
in health care and pharmaceuticals. Toronto. Presenter: Lexchin, J.
December 1, 2016. SDGs, Anti-corruption and Equity: Leave No-one Behind to Deliver on the
SDGs Mackey TK. 17th International Anti-Corruption Conference (IACC), Panama City, Panama.
Presenter: Mackey, TK.
January 25, 2017. Commentary on Katrina Perehudoff, "Unpacking the 'Core Content' of
Essential Medicines Under the Right to Health", Dalla Lana School of Public Health. Presenter:
Lemmens, T.
March 2017. Seminar on expedited drug approval programs in Canada and the United States,
Centre for Healthcare Resilience and Implementation Science, Macquarie University, Sydney,
Australia. Presenter: Lexchin, J.
March 8, 2017. Essential medicines. Toronto, Ontario, Canada. Presenter: Persaud, N. Ontario
Committee to Evaluate Drugs.
March 22, 2017. Participation Panel on "The Opioid Crisis", event organized by the Health Law
Club, Faculty of Law. Presenter: Lemmens, T.
April 4, 2017. Securing the Drug Supply Chain: Using Blockchain to Fight Fake Medicines.
Mackey TK. IEEE Blockchain Summit, 2017. IEEE International Conference on Cloud
Engineering, Simon Fraser University, Vancouver, British Columbia, Canada. Presenter: Mackey,
TK.
April 7, 2017. Promoting Transparency, Accountability and Participation through a Multi-
Stakeholder Initiative: Lessons from the Medicines Transparency Alliance. Consortium of
Universities for Global Health in Washington DC. Presented by: Kohler, JC.
April 8, 2017. Fighting Fakes with Tech: Exploring Digital Solutions to Combat Fake Medicines.
Session "Fake Medicines: An Unseen Threat to Global Health" Mackey TK. 8th Annual Global
Health Conference, Consortium of Universities for Global Health, Washington DC. Presenter:
Mackey TK.
April 11, 2017. Essential medicines and data transparency. Ottawa Ontario, Canada. Presenter:
Persaud, N. Prescription for equity. National conference of Canadian Health Coalition.
April 25, 2017. Blockchain: Modernizing Security of the Global Drug Supply Chain. A Landscape
View of Applications and Considerations of Blockchain Across Industries. Mackey TK. IEEE
Standards Association, Computer History Museum, San Jose, CA. Presenter: Mackey, TK.
11
May 2017. Panelist, Seniors' Housing as part of Housing Policy Forum Series sponsored by Social
Planning Toronto, Wellesley Institute, Toronto Alliance to End Homelessness and City of
Toronto, Toronto. Presenter: Lexchin, J.
May 2, 2017. Curing Health Inequalities with Technology & Social Reform. Mackey TK. Health
Technology Forum 2017, Stanford University, CA. Presenter: Mackey, TK.
May 8, 2017. Data transparency and unpublished. Toronto, Ontario, Canada. Presenter: Persaud,
N. HOO retreat.
May 9, 2017. Educational Panelist: Webinar "Securing the Pharma Supply Chain with
Blockchain", IEEE Standards Association. Presenter: Mackey, TK.
June 2017. Myths and realities about why US drug prices are so high. PharmedOut Conference,
Washington. Presenter: Lexchin, J.
June 2017. Panelist, Ensuring safety, efficacy and access to medical products in the age of global
deregulation. Yale Collaboration for Economic Integrity and Transparency and European Public
Health Alliance, New Haven Connecticut. Presenter: Lexchin, J.
June 6, 2017. The Last Mile: Design Elements that incentivize the Use of Blockchain Beyond
Compliance. Mackey TK. IEEE Pharma Supply Blockchain Forum, Johns Hopkins University,
Rockville, MD. Presenter: Mackey, TK.
June 22, 2017. RCT of free essential medicines. North American Primary Care Research Group
Practice based Research Network Conference. Washington, USA. Presenter(s): Persaud, N.
July 27, 2017. Do country characteristics explain Essential Medicines List differences? Jiang M,
Shaikh R, Bali A, Oronsaye E, Woods H, Drozdzal G, Rajakulasingam Y, Wang R, Persaud N.
Keenan Research Summer Student Poster Competition 2017. St. Michael's Hospital. Senior
Responsible Author: Nav Persaud. Presenter: Persaud, N.
August 2017. The danger of imperfect regulation: how Purdue was allowed to push Oxycontin.
Public lecture, Unitarian Church Vancouver. Presenter: Lexchin, J.
August 31, 2017. Educational Speaker: Webinar/Webex "Case Study of Counterfeit Avastin: A
Story of Economic Opportunity and Pharmaceutical Crime", US FDA Workgroup on
Economically Motivated Adulteration. Presenter: Mackey, TK.
September 2017. Where do we go from here: physicians, the medical profession and industry at
Health Action International AGM, Berlin. Presenter: Lexchin, J.
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September 2017. Panelist, Beyond medicalization: an international view of MD roles in long-term
care, Re imagining Long-term Residential Care project, Toronto. Presenter: Lexchin, J.
September 7, 2017. Carefully selected, Easily Accessible, at no charge Medications: CLEAN
Meds Trial. Breezy Ridge, Muskoka, Ontario, Canada. Presenter(s): Persaud, N. PSI Graham
Farquharson Knowledge Translation Fellows Retreat.
September 12, 2017. Conflict of Interest Policy for Committee Members at Health Quality
Ontario. Panel on Health Quality Ontario Board of Directors. 90 min lecture. Presenter(s): Persaud
N, Patel R, Apkon M, Tunks E. Provincial talk at Health Quality Ontario.
September 22, 2017. People's health matters seminar - who benefits from opioid prescribing?
Ethics of Caring for People with Addictions: Power, Politics, and Practicalities - An Ethics
Education Event. St. John's, Newfoundland, Canada. Presenter: Persaud, N.
September 26, 2017. for the Pharma Supply Chain. Mackey, TK. Distributed Health 2017
Conference. Presenter: Mackey, TK.
September 29, 2017. The Pharmaceutical Triple Aim: Policies to promote universal accessibility,
appropriateness, and affordability of prescription drugs. Canadian Institutes of Health Research,
Ottawa, Ontario, Canada. Presenter(s): Persaud, N. CIHR Best Brains Exchange.
September 29, 2017. Speaker, Governance and corruption in the pharmaceutical sector: causes
and consequences, WHO Collaborating Centre for Governance, Accountability and Transparency
in the Pharmaceutical Sector, Toronto. Presenter: Mackey, TK.
September 29, 2017. Leveraging the Sustainable Development Goals to Tackle Pharmaceutical
Corruption. Mackey TK. World Health Organization Collaborating Centre on Pharmaceutical
Governance, Accountability and Transparency, University of Toronto. Presenter: Mackey, TK.
October 9, 2017. Going Digital: A Landscape View of Digital Technologies to Combat the Fake
Medicines Trade. Mackey TK. SciX 2017 Conference, Reno, Nevada. Presenter: Mackey, TK.
13
Academic Publications (alphabetical order):
Annaloro, John, and Tim K. Mackey. “Policy Implications and Paths Forward for Post-Brexit
Biotech.” Nature Biotech 35 (2017): 710-711.
Bhattacharyya, Onil, Kathryn Mossman, John Ginther, Leigh Hayden, Raman Sohal, Jieun Cha,
Ameya Bopardikar et al. "Assessing health program performance in low-and middle-income
countries: building a feasible, credible, and comprehensive framework." Globalization and Health
11, no. 1 (2015): 51.
Bhattacharyya, Onil, Diane Wu, Kathryn Mossman, Leigh Hayden, Pavan Gill, Yu-Ling Cheng,
Abdallah Daar et al. "Criteria to assess potential reverse innovations: opportunities for shared
learning between high-and low-income countries." Globalization and Health 13, no. 1 (2017): 4.
Burden, Andrea, Andrea Gruneir, Michael J. Paterson, and Suzanne M. Cadarette. "Examining
Exposure Misclassification of Oral Bisphosphonate Therapy and the Associated Fracture Risk: A
Cohort Study." Advances in Pharmacoepidemiology and Drug Safety 4, no. 188 (2015): 2167-
1052.
Cadarette, Suzanne M., Joann K. Ban, Giulia P. Consiglio, Cody D. Black, David Dubins,
Alexandra Marin, and Mina Tadrous. "Diffusion of Innovations model helps interpret the
comparative uptake of two methodological innovations: co-authorship network analysis and
recommendations for the integration of novel methods in practice." Journal of Clinical
Epidemiology 84 (2017): 150-160.
Cadarette, Suzanne M., Mina Tadrous, Joseph Delaney, Joshua J. Gagne, Shirley V. Wang, H.
Whitaker, J. Hallas, and Malcolm Maclure. “Control yourself: guidance for the application and
reporting of self-controlled study designs in pharmacoepidemiology [abstract].”
Pharmacoepidemiol Drug Safety 26 (2017): 3.
Consiglio, Giulia P., Andrea M. Burden, Malcolm Maclure, Lisa McCarthy, and Suzanne M.
Cadarette. "Case‐crossover study design in pharmacoepidemiology: Systematic review and
recommendations." Pharmacoepidemiology and Drug Safety 22, no. 11 (2013): 1146-1153.
Cosgrove, Lisa, Allen F. Shaughnessy, Shannon M. Peters, Joel R. Lexchin, Harold Bursztajn, and
Lisa Bero. “Conflicts of interest and the presence of methodologists on guideline development
panels: a cross-sectional study of clinical practice guidelines for major depressive disorder.”
Psychotherapy and Psychosomatics (2017): 168-170.
Cuomo, Raphael E., Robert L. Seidman, and Tim K. Mackey. "Country and regional variations in
purchase prices for essential cancer medications." BMC Cancer 17, no. 1 (2017): 566.
Cuomo, Raphael E., and Tim K. Mackey. "The availability of essential cancer medication: An
analysis of national formularies." Journal of Cancer Policy 12 (2017): 49-54.
14
Habibi, Roojin, Joel R. Lexchin, Barbara Mintzes, and Anne Holbrook. "Unwarranted claims of
drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes
promoted appropriately?" British Journal of Clinical Pharmacology (2017).
Hemminki, Elina, Joel R. Lexchin, and Nicolas Rasmussen. "Evolution of Physician-Industry
Relationships in Producing Knowledge of Drug Therapy-Comparison of the United States and
Finland." SSRN Abstract (2017).
Hensel, Jennifer M., Jay Shaw, Lianne Jeffs, Noah M. Ivers, Laura Desveaux, Ashley Cohen,
Payal Agarwal et al. "A pragmatic randomized control trial and realist evaluation on the
implementation and effectiveness of an internet application to support self-management among
individuals seeking specialized mental health care: a study protocol." BMC Psychiatry 16, no. 1
(2016): 350.
Jandoc, Racquel, Andrea M. Burden, Muhammad Mamdani, Linda E. Lévesque, and Suzanne M.
Cadarette. "Interrupted time series analysis in drug utilization research is increasing: systematic
review and recommendations." Journal of Clinical Epidemiology 68, no. 8 (2015): 950-956.
Kalyanam, Janani, Takeo Katsuki, Gert Lanckriet, and Tim K. Mackey. "Exploring trends of
nonmedical use of prescription drugs and polydrug abuse in the Twittersphere using unsupervised
machine learning." Addictive Behaviors 65 (2017): 289-295.
Kalyanam, Janani, and Tim K. Mackey. "A Review of Digital Surveillance Methods and
Approaches to Combat Prescription Drug Abuse." Current Addiction Reports 4, no. 4 (2017): 397-
409.
Katsuki, Takeo, Tim K. Mackey, and Raphael Cuomo. "Establishing a link between prescription
drug abuse and illicit online pharmacies: analysis of Twitter data." Journal of Medical Internet
Research 17, no. 12 (2015).
Klein, Peter, Joseph Mahoney, Anita McGahan, and Christos Pitelis. "Organizational governance
adaptation: Who is in, who is out, and who gets what." Academy of Management Review (2017):
459.
Kohler, Jillian, Nicholas Mitsakakis, Faridah Saadat, Danalyn Byng, and Martha Gabriela
Martinez. "Does Pharmaceutical Pricing Transparency Matter? Examining Brazil’s Public
Procurement System." Globalization and health 11, no. 1 (2015): 34.
Kohler, Jillian C. “Governance and Corruption in the Pharmaceutical Sector.” In Pharmaceutical
Public Policy, edited by Thomas Fulda, Alan Lyles, and Albert L. Wertheimer, 91-104. RC Press,
2016.
15
Kohler, Jillian C., and Tim K. Mackey. “Treating Health and Pharmaceutical Corruption: The
Need for a Multi-stakeholder U.N. Partnership.” International Affairs Forum (2016).
Kohler, Jillian C., Martha Gabriela Martinez, Michael Petkov, and James Sale. "Corruption in the
pharmaceutical sector: diagnosing the challenges." UK: Transparency International (2016).
Lemmens, Trudo. "Restoring the Integrity of the Pharmaceutical Science Record: Two Tales of
Transparency." Jotwell Journal (2016): 246.
Lexchin, Joel R., Peter Doshi, Janice E. Graham, Matthew Herder, Tom Jefferson, Trudo
Lemmens, Barbara Mintzes, and Nav Persaud. “Response to Health Canada discussion paper on
Regulations Amending the Food and Drug Regulations (on safety reporting).” Health Canada
(2017).
Lexchin, Joel R., Peter Doshi, Janice E. Graham, Matthew Herder, Tom Jefferson, Trudo
Lemmens, Barbara Mintzes, and Nav Persaud. “Response to Health Canada discussion paper on
the release of clinical data. Health Canada.” (2017).
Lexchin, Joel R., Quinn Grundy, Alice Fabbri, Barbara Mintzes, and Lisa Bero. “Brief to the
Therapeutic Goods Administration regarding strengthening monitoring of medicines in Australia.”
(2017).
Lexchin, Joel R. "Drug prices: How do we get to a better place?" Canadian Medical Association
Journal 189, no. 23 (2017): E792-E793.
Lexchin, Joel R. "Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort
Study." Value in Health, no. 8 (2017): 1139-1142.
Lexchin, Joel R. "Medicines Save, Medicines Kill." Drug Safety 4, no 6 (2017): 457-459.
Lexchin, Joel R. "Myths and Realities About Why Prescription Drug Prices in the United States
Are So High." Pharmaceutical Medicine 31, no. 3 (2017): 143-148.
Lexchin, Joel R. "Priority reviews: innovation and safety." Canadian Medical Association
Journal 189, no. 26 (2017): E895-E895.
Lexchin, Joel R. "Publication of confirmatory studies required by health Canada for drugs
approved under a notice of compliance with conditions: a cohort study." CMAJ Open 5, no. 2
(2017): E295.
Lexchin, Joel R. “Response to Health Canada consultation paper on Mandatory Reporting of
Adverse Drug Reactions by healthcare institutions.” Health Canada (2017).
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Lexchin, Joel R. “Response to Health Canada discussion paper on Draft Guidance Document for
Notifying Health Canada of Foreign Risk.” Health Canada (2017).
Lexchin, Joel R. “Response to Draft Guidance Document for Notifying Health Canada of Foreign
Risk.” Health Canada (2017).
Lexchin, Joel R. “Six myths about pharmacare.” Health Law in Canada (2017): 44-51.
Lexchin, Joel R. "The Pharmaceutical Industry and the Canadian Government: Folie à
Deux." Healthcare Policy 13, no. 1 (2017): 10-16.
Lexchin, Joel R. "The relation between promotional spending on drugs and their therapeutic gain:
a cohort analysis." Canadian Medical Association Journal open 5, no. 3 (2017): E724-728.
Mackey, Tim K., and Bryan A. Liang. "After Amarin v FDA: What will the future hold for off-
label promotion regulation?" Mayo Clinic Proceedings 91, no. 6 (2016): 701-706.
Mackey, Tim K., Jillian C. Kohler, William D. Savedoff, Frank Vogl, Maureen Lewis, James Sale,
Joshua Michaud, and Taryn Vian. "The disease of corruption: views on how to fight corruption to
advance 21st century global health goals." BMC Medicine 14, no. 1 (2016): 149.
Mackey, Tim K., and Virginia J. Schoenfeld. "Going “social” to access experimental and
potentially life-saving treatment: an assessment of the policy and online patient advocacy
environment for expanded access." BMC Medicine 14, no. 1 (2016): 17.
Mackey, Tim K., and Bryan A. Liang. "In Reply—Electronic Health Records and Drugs Prescribed
for Off-label Indications." In Mayo Clinic Proceedings 92, no. 4 (2017): 684-685.
Mackey, Tim K., Janani Kalyanam, Takeo Katsuki, and Gert Lanckriet. "Machine learning to
detect prescription opioid abuse promotion and access via Twitter." American Journal of Public
Health (2017).
Mackey, Tim K., Jillian C. Kohler, Maureen Lewis, and Taryn Vian. "Combating corruption in
global health." Science Translational Medicine 9, no. 402 (2017): eaaf9547.
Mackey, Tim K., and Gaurvika Nayyar. "A review of existing and emerging digital technologies to
combat the global trade in fake medicines." Expert Opinion On Drug Safety 16, no. 5 (2017): 587-
602.
Marshall, Deborah C., Beverly Moy, Madeleine E. Jackson, Tim K. Mackey, and Jona A.
Hattangadi-Gluth. "Distribution and patterns of industry-related payments to oncologists in 2014."
Journal of the National Cancer Institute 108, no. 12 (2016).
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Martinez, Martha Gabriela, and Jillian C. Kohler. "Civil society participation in the health system:
the case of Brazil’s Health Councils." Globalization and Health 12, no. 1 (2016): 64.
Martinez, Martha Gabriela, Jillian C. Kohler, and Heather McAlister. “Chapter 14: Corruption in
the Pharmaceutical Sector.” In The Handbook of Business and Corruption: Cross-Sectoral
Experiences, edited by Michael Abländer and Sarah Hudson, 329-361. Emerald Publishing
Limited, 2017.
Menkes, David B., and Joel R. Lexchin. “Relationships with industry are undermined by
unconscious bias.” BMJ (2017): 356.
Morgan, Steven G., Winny Li, Brandon Yau, and Nav Persaud. "Estimated effects of adding
universal public coverage of an essential medicines list to existing public drug plans in
Canada." Canadian Medical Association Journal 189, no. 8 (2017): E295-E302.
Moscou, Kathy, Jillian C. Kohler, and Anita McGahan. "Governance and pharmacovigilance in
Brazil: a scoping review." Journal of Pharmaceutical Policy and Practice 9, no. 1 (2016): 3.
Moscou, Kathy, and Jillian C. Kohler. "Matching safety to access: global actors and
pharmacogovernance in Kenya-a case study." Globalization and Health 13, no. 1 (2017): 20.
Mossman, Kathryn, Onil Bhattacharyya, Anita McGahan, and Will Mitchell. “Scaling Up
Strategies that Work: Business Expertise Helps Expand Primary Care in Low- and Middle-Income
Countries.” HBR.org. (2017).
Nilanjana, Dutt, Olga V. Hawn, Elena Vidal, Aaron Chatterji, Anita McGahan, and Will Mitchell.
“How do firms and markets co-develop? Exploring the role of incubators in emerging market
economies.” Academy of Management Journal 59 (2016): 766-790.
Persaud, Nav, and Peter Doshi. "North American regulatory agencies can and should make clinical
trial data publicly available." Canadian Medical Association Journal, no. 2 (2016): 96-97.
Persaud, Nav, Taehoon Lee, Haroon Ahmad, Winny Li, Michael Sergio Taglione, Yathavan
Rajakulasingam, Norman Umali et al. "Protocol for a randomized controlled trial evaluating the
effects of providing essential medicines at no charge: the Carefully selected and Easily Accessible
at No Charge Medicines (CLEAN Meds) trial." BMJ open 7, no. 5 (2017): e015686.
Romain, Sandra J., Jillian C. Kohler, and Kue Young. "Policy versus practice: a community-based
qualitative study of the realities of pharmacy services in Nunavut, Canada." Journal of
Pharmaceutical Policy and Practice 8, no. 1 (2015): 22.
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Setayesh, Sogol, and Tim K. Mackey. "Addressing the impact of economic sanctions on Iranian
drug shortages in the joint comprehensive plan of action: promoting access to medicines and
health diplomacy." Globalization and Health 12, no. 1 (2016): 31.
Shannon Gibson, Renata Axler, and Trudo Lemmens, “Transparency of Biobank Access in
Canada: An Assessment of Industry Access and the Availability of Information on Access Policies
and Resulting Research.” Journal of Empirical Research on Human Research Ethics (2017): 310-
325.
Shaughnessy, Allen F., Akansha Vaswani, Bonnie K. Andrews, Deborah R. Erlich, Frank
D’Amico, Joel R. Lexchin, and Lisa Cosgrove. "Developing a Clinician Friendly Tool to Identify
Useful Clinical Practice Guidelines: G-TRUST." The Annals of Family Medicine 15, no. 5 (2017):
413-418.
Shnier, Adrienne, and Joel Lexchin. "Continuing medical education and pharmaceutical industry
involvement: An evaluation of policies adopted by Canadian professional medical
associations." International Journal of Risk & Safety in Medicine 29, no. 1-2 (2017): 1-16.
Shoucri, Rami, and Navindra Persaud. "Investigating pharmaceutical marketing in Canada using
American prosecutions." International Journal of Risk & Safety in Medicine 26, no. 3 (2014): 147-
153.
Tadrous, Mina, Muhammad M. Mamdani, David N. Juurlink, Murray D. Krahn, Linda E.
Lévesque, and Suzanne M. Cadarette. "Performance of the disease risk score in a cohort study with
policy-induced selection bias." Journal of Comparative Effectiveness Research 4, no. 6 (2015):
607-614.
Taglione, Michael S., Haroon Ahmad, Morgan Slater, Babak Aliarzadeh, Richard H. Glazier,
Andreas Laupacis, and Nav Persaud. "Development of a preliminary essential medicines list for
Canada." Canadian Medical Association Journal open 5, no. 1 (2017): E137.
Thorsteinsdóttir, Halla, Natasha Ovtcharenko, and Jillian C. Kohler. "Corporate social
responsibility to improve access to medicines: the case of Brazil." Globalization and Health 13,
no. 1 (2017): 10.
Tringale, Kathryn R., Deborah Marshall, Tim K. Mackey, Michael Connor, James D. Murphy, and
Jona A. Hattangadi-Gluth. "Types and distribution of payments from industry to physicians in
2015." Jama 317, no. 17 (2017): 1774-1784.
Vakili, Keyvan, and Anita McGahan. “Healthcare’s Grand Challenge: Basic Science on Diseases
that Primarily Afflict the Poor.” Academy of Management Journal (2016): 1917–1939.
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Vian, Taryn, and Jillian C. Kohler. "Medicines Transparency Alliance (MeTA): Pathways to
Transparency, Accountability and Access." World Health Organization (2016).
Vian, Taryn, Jillian C. Kohler, Gilles Forte, and Deirdre Dimancesco. "Promoting transparency,
accountability, and access through a multi-stakeholder initiative: lessons from the medicines
transparency alliance." Journal of Pharmaceutical Policy and Practice 10, no. 1 (2017): 18.
Wang, Annie, Trudo Lemmens, and Nav Persaud. "Medication access via hospital
admission." Canadian Family Physician 63, no. 5 (2017): 344-34 7.
News Articles & Media Outputs (chronological order):
October 2015
Herder, Matthew, and Trudo Lemmens. “Diclectin Data: Testing Canada’s New Transparency
Law.” British Medical Journal Blog, October 27, 2015.
http://blogs.bmj.com/bmj/2015/10/27/diclectin-data-testing-canadas- new-pharmaceutical-
transparency-law/
November 2015
Kohler, Jillian C. "Valeant’s drug pricing is just part of the reality of Big Pharma." The Globe and
Mail, November 7 2015. https://www.theglobeandmail.com/report-on-business/rob-
commentary/valeants-drug-pricing-is-just-part-of-the-reality-of-big-pharma/article27163190/
December 2015
Mackey, Tim K. EPIPEN Price. By KUSI News, December 15, 2015.
http://www.kusi.com/clip/12696930/epipen- price
April 2016
Mackey, Tim K. “Commentary: Amarin vs. FDA and Off-label Promotion.” UCSD Health
Sciences Blog, April 12, 2016.
http://ucsdhealthsciences.tumblr.com/post/142698354620/commentary-amarin-vs-fda-and-off-
label- promotion
June 2016
Herder, M., Trudo Lemmens, Joel R. Lexchin, Barbara Mintzes, and Tom Jefferson.
"Pharmaceutical transparency in Canada: Tired of talk.” BMJ Blogs, June 16, 2016.
http://blogs.bmj.com/bmj/2016/06/06/pharmaceutical-transparency-in-canada-tired-of-talk/
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July 2016
Mintzes, B., Joel R. Lexchin, Matthew Herder, Tom Jefferson, and Trudo Lemmens. “Is
Pharmaceutical Transparency in Canada All Just Talk?” Policy Options, July 12 2016.
http://policyoptions.irpp.org/magazines/july-2016/is-pharmaceutical-transparency-in-canada-all-
just-talk/
Lemmens, Trudo. “Restoring the Integrity of the Pharmaceutical Science Record: Two Tales of
Transparency.” JOTWELL. July 14, 2016. http://health.jotwell.com/restoring-the-integrity-of-the-
pharmaceutical-science- record-two-tales-of-transparency/
August 2016
Mackey, Tim K. "How to pay less for your prescription drugs, legally.” CNN News, August 25,
2016: http://www.cnn.com/2016/08/25/health/where-to-get-cheap-drugs/
September 2016
Petkov, Michael. “Catalyzing Anticorruption Efforts in the Pharmaceutical Sector–Collaboration
Is Key.” The Global Anticorruption Blog: Law, Social Science, and Policy, September 8, 2016
https://globalanticorruptionblog.com/2016/09/08/guest-post-catalyzing-anticorruption-efforts-in-
the- pharmaceutical-sector-collaboration-is-key/
January 2017
Mackey, Tim K. “Social Media is Affecting Patients’ Access to Investigational Drugs.” AHC
Media, January 1, 2017. https://www.ahcmedia.com/articles/139817-study-social-media-is-
affecting-patients-access-to-investigational-drugs
February 2017
Vogel, L. "Experts blame feds for pharma corruption." CMAJ News, February 6, 2017.
http://cmajnews.com/2017/02/06/experts-blame-feds-for-pharma-corruption-cmaj-109-5384/
March 2017
Lexchin, Joel R. “Trump loosening FDA regulations could hurt Canadians.” Healthy Debate,
March 15, 2017. http://healthydebate.ca/opinions/trump-fda-drug-regulation-canada
Mackey, Tim K. Potential limitations of the new health domain and quality of information online.
By Vice, March 2017. https://motherboard.vice.com/en_us/article/xyk79w/theres-a-new-health-
domain-and-it-could-save-you-from-fake-medicine
May 2017
Lexchin, Joel. “Joel Lexchin: Health Canada promises a new era in transparency.” Thebmjopinion,
May 23 2017. http://biogs.bmj.com/bmj/2017/05/23/joel-lexchin-health-canada-promises-a-new-
era-in transparency/
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June 2017 Mackey, Tim K. “Cost and transparency of hospital billing practices.” AHC Media, June 2017.
https://www.ahcmedia.com/articles/140796-are-hospital-billing-practices-unethicalchargemaster-
still-used-to-boost-revenue
July 2017 Lemmens, Trudo, and Paul D. Thacker. “Time for Full Transparency on Pharmaceutical Data.”
The Toronto Star, July 7, 2017. https://www.thestar.com/opinion/commentary/2017/07/07/time-
for-full-transparency-on-pharmaceutical-money.html
August 2017 Mackey, Tim K. Global health corruption. By BBC World Service Health Check segment, August
2017. http://www.bbc.co.uk/programmes/p05b9q72
Mackey, Tim K. Blockchain technology and pharmaceutical supply chain. By Pharmaceutical
Technology, August 2017. http://www.pharmtech.com/node/339106
September 2017
Lexchin, Joel R. “We've missed an opportunity to debate FDA funding and user fees.”
Thebmjopinion, September 6, 2017. http://blogs.bmj.com/bmj/2017/09/06/joel-lexchin-weve-
missed-an opportunity-to-debate-fda-funding-and-user-fees/
Thacker, Paul D., and Trudo Lemmens. “Physician-payment closure is a good first step: but it’s
not enough.” The Globe and Mail, September 27, 2017.
https://beta.theglobeandmail.com/opinion/disclosure-of-pharmaceutical-companies-payments-to-
doctors-is-a-good-first-step-but-its-not-
enough/article36414054/?ref=http://www.theglobeandmail.com&
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Summary 2015 Activities
The WHO CCGAT convened in October 2015. It is currently led by Dr. Jillian C. Kohler who
works with a large multidisciplinary team of local and global research fellows. The expertise of
said professionals informed the direction and planning for this research and training program.
2016 Activities
Several workshops and symposiums were hosted in alignment with the program goals. Highlights
(e.g. agendas and presentations) from these academic events are captured and further described on
our WHO CC website.
2017 Activities
Several workshops, symposiums and one summer course was hosted this past year in alignment
with the program goals. Several publications (i.e. conferences, academic articles) were
disseminated to reflect the current work of this WHO CC.
Future Directions
Moving forward, the WHO Collaborating Centre for Governance, Accountability and Transparency in the
Pharmaceutical Sector aims to continue to provide a global venue for discussing and researching critical
issues related to good governance in medicines.